OxyElite Pro Causing Liver Damage In Hawaii?

USPLabs statement: "The cluster of liver issues in Hawaii is a complete mystery and nothing like this has ever been associated with OxyELITE Pro in all of the years our products have been in the market."

A federal investigation is underway into reports of acute non-viral hepatitis in Hawaii, with many of the cases being linked to a dietary supplement product labeled as OxyElite Pro.

The US Food and Drug Administration (FDA) along with the Centers for Disease Control and Prevention (CDC) and the Hawaii Department of Health (DOH) launched the investigation after 29 cases of acute non-viral hepatitis were reported on the islands, 11 of which led to hospitalizations, two cases have received liver transplants and one person has died.

Twenty-four of these cases share a common link to a dietary supplement product labeled as OxyElite Pro, said FDA.

Liver issues are a ‘complete mystery’

In a statement to NutraIngredients-USA, USPlabs LLC, the company behind the product, said it stands by the safety of all of its products.

“The company is cooperating with FDA on reports coming out of Hawaii. The cluster of liver issues in Hawaii is a complete mystery and nothing like this has ever been associated with OxyELITE Pro in all of the years our products have been in the market,” stated the company.

“Out of an abundance of caution, the company has ceased domestic distribution of OxyElite Pro with the Purple Top and OxyElite Pro Super Thermo Powder until the investigation has been completed. The company continues to believe these versions are safe and are not the cause of the cluster of liver toxicity that has occurred in Hawaii.”

According to the FDA, the Dallas, Texas-based company has also informed the Agency that it believes counterfeit versions of OxyElite Pro are being marketed in the US and have been on the US market for some time. FDA is also investigating whether counterfeit product is related to any of the cases of acute hepatitis.

The product is sold nationwide through a wide range of distribution channels, including the internet and retail stores that sell dietary supplements. The CDC is reportedly investigating other cases of liver injury nationwide that may be related.

The USPLabs statement continued: “We know of no credible evidence linking OxyELITE Pro to liver issues. The ingredients have been studied for safety, are consumed in the food supply and widely used in dietary supplements. The studies and consumption history show no negative liver issues.

“Due to multiple products within the OxyELITE Pro brand, it may be confusing as to which products are being looked at. The specific products are the original OxyELITE Pro with DMAA, OxyELITE Pro with the “Purple Top” and OxyELITE Pro Super Thermo Powder. The original version with DMAA has not been manufactured or distributed since early 2013."

Caution

While the investigation is ongoing, the FDA is advising consumers to stop using any dietary supplement products labeled as OxyElite Pro.

“The epidemiological investigation is being conducted by the Hawaii DOH and the CDC,” explained FDA in astatement. “As part of FDA’s associated investigation, the agency is reviewing the medical records and histories of patients identified by the Hawaii DOH. The FDA is also analyzing the composition of product samples that have been collected from some of these patients.

“Additionally, the FDA is inspecting the facilities involved in manufacturing the product and reviewing production and product distribution records.”

It sounds like these peeps bought counterfeit Oxyelite supps. In my opinion, its pretty simple, the investigators/police simply need to find the vendor that these peeps bought the items from, then once they determine that there selling couterfeit supps, send those a$$holes to jail. Now this is making me really nervous, since I bought a few bottles from Amazon. I wonder if the counterfeit supps were noticeably different than the legit ones.

1.) # of pills is more or less than 90. (one example from someone who received a fake Oxyelite) :I have 4 bottles, 3 are 90 ct, 1 is 180 ct..
2.) various lot and exp #.
3.) One bottle in particular has no effect whatsoever and I have been using OEP for a while
4.) The label is different form the other three, ("R" vs "TM")
5.) Above USPLabs logo, different color purple
6.) Ingredient list does not end in "...bark extract"
7.) The picture of the capsule has squared off instead of rounded ends.
8.) The printing and font look different and altered. All 3 known good bottles are consistent versus the above mentioned oddities.

Hope this helps! I'm definitely thoroughly reviewing my 3 bottles I bought off Amazon vs my legit source :) A major thank you to AlwaysSwoleUp at Bodybuilding.com for your review!!!

Always investigate items on Amazon which aren't sold by Amazon. Thousands of Amazon third party sellers are shady as ****, and Amazon will actually refund your money if in fact the product you've received is a fake (I've been refunded MANY times, and didn't even have to return the product). A lot of counterfeit stuff out there, remember counterfeit Craze preworkout supplement?

FDA is trying to shut these guys down, it seems. Tearing them apart over their DMAA and then come to find DMAA isn't harmful at all if dosed responsibly...

The thing that worries me is possibly someone making counterfeit OxyElite with current OTC steroids to induce similar effects. Something like Epistane or H-Drol could be in there. Let's hope not because the FDA will see it and then go on a rant demanding that these get put on controlled substances list...

This is ridiculous. I've been using this stuff for years on and off (consistently) and my liver is fine. Stop buying counterfeits and saving 10$?? MAYBE? Just get the real thing from a real site and enjoy..

I just find it funny that its isolated to just Hawaii...If there was some mass counterfeit scandal going on it would be more dispersed.

Just my .02-which isnt worth much more than .02

Actually, it makes perfect since. It would be much, much harder to get caught doing it in Hawaii. 2 reasons why I'd do it there (if I were a counterfeit mfg):

1) Doesn't enter the contiguous states = less officials touching the product = less likely to get caught
2) Because most things come by way of boat to Hawaii, due to lead times vs demand, supply is always choked which means prices are always very high over there. Seriously, everything is priced 50 - 300% higher due to supply shortage and the cost of the distribution. Now I'd assume a counterfeit mfg is making their products much cheaper than the original and even better to send it to a market that pays premium for supplements. Especially if its coming from China or the far east.

thats the point im making-I think the fugazzis are limited to just hawaii. I doubt there is a mass oxyelite fake scandal goin on around the US.

but hawaii is also known for partying like its 99 with prince at a disco. It wouldnt surprise me either if some crankshaft that had a little too much smarts for his own safety said "hmm...i bet if i mix this with this itll get you HIIIGHH" so he did it, told a few buddies, then they fried their livers because they were tards